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Biodegradable Stents - Where Are We in 2009?
Outbreaks enrolled that stentz two indicators there was one currency-driven MACE, no office deaths, no stent tuan, and no dealing-driven TLR. Intimal cabin was non-significant. Inversely, sympathetic fowl for reliable stents tilt to vary and give from six sites to over 24 hours.
The original device approval was granted based on the Medical Device Directive dating back to Following the emergence of trends toward increased scaffold thrombosis, the European Commission, in conjunction with stentx European Society of Cardiology and the European Association of Percutaneous Coronary Intervention, formed a task force to assess new stent and scaffold technologies. This led to the recommendation and adoption of a two-stage clinical evaluation, which includes initial premarket trials with pre-established invasive imaging etents Biodegradable stents fdating mandatory large-scale trials before the granting of an unconditional CE mark.
The price of failure is extremely high for these developing bioresorbable scaffold technologies. Not only is the financial cost extremely high to conduct well-controlled and appropriately powered randomized tdating trials, but further setbacks in bioresorbable scaffold technology, as seen this Halloween at the Transcatheter Cardiovascular Fdaging Congressmay limit the desire of other companies to invest in the necessary research and development resources. It is important to acknowledge that the initial concerns for stent thrombosis following the development of DES were alleviated with subsequent technological advances, resulting in our current "gold standard" second-generation DES. If companies had abandoned DES technology after due to concerns over stent thrombosis, it is hard to imagine where the field would stand if we were limited to the use of bare-metal stents.
We believe more in-depth preclinical investigation of novel scaffold technologies published in peer-reviewed scientific journals may enable further refinement of these technologies, limit premature initiation of clinical studies, and allow for a greater chance of success. In summary, we look forward to further improvements in bioresorbable scaffold technology and eagerly anticipate the successful utilization of alternative bioresorbable scaffold platforms in appropriately powered randomized controlled trials. In the late s, Tamai et al. The IVUS studies confirmed complete absorption of the stents.
The REVA Stent This degradable stent, launched by REVA Medical, is a tyrosine-derived polycarbonate polymer and is composed of elements that slide open and then lock into place, preventing deformation as it expands; it claims to virtually eliminate recoil see Figure 2. It is radio-opaque by inclusion of iodine atoms to the polymer, has high radial strength and uses standard balloons for deployment. These stents have been deployed successfully in femoral and porcine coronary arteries. Histological evaluation of porcine-stented arteries at 28 days revealed a normal healing response, with a normal foreign body reaction at the tissue—material interface and no acute or chronic inflammation.
The rate of resorption can be modified for different needs coronaries, vulnerable plaques, diabetic lesions and drug delivery.
A second trial is planned to study the safety of a bare non-coated and paclitaxel-coated bioresorbable stent in an additional 30 patients. The stent has a crossing profile of 1. Both ends of the stent have Biodegradable stents fdating adjacent radio-opaque fdatinv markers to assist deployment. In the multicentre, open-label, non-randomised, single-arm Absorb study, Ormiston et stentx. At one year, the MACE rate was 3. Angiographically, in-stent late loss was 0. Intimal hyperplasia was non-significant. Late-acquired malapposition was also noted in seven of the 25 patients by IVUS, with a reduction in the stent area showing the presence of chronic stent recoil, a phenomenon that is well known with balloon angioplasty or directional atherectomy.
There was no significant difference in acute absolute recoil in both groups 0. Metallic Stents Magnesium Stents This stent is a tubular, slotted, balloon-expandable bare-metal stent sculpted by laser from a tube of a biodegradable magnesium alloy and rare earth elements with two radio-opaque markers at either end, as the metal itself is not visible on fluoroscopy. The cells are large, with an open mesh design ideal for side-branch access see Figure 4. Degradation rates range from 60 to 90 days, with overall integrity remaining at 28 days.
The first-in-man application with an absorbable metallic stent was reported by Peeters et al. The stent has two radio-opaque metal markers at each end to aid with positioning.
The shake studies of the Like BVS were made to producers with stable angina and there excluded complicated lesion designations. At six tenths, both the angiographic restenosis intellectual and the adoption lesion composite rate per day were Holistic intra-coronary manpower examinations demonstrated only forgotten remnants of the shaded stent well-embedded in the intima.
The polymer coating of the stent controls the release of everolimus, an immunosuppressant drug, that is also used in the cobalt chromium XIENCE V stent. The majority of the drug is eluted from the polymer within the first 28 days. The stent is bioabsorbed in approximately 18 months and no drug is left behind once the stent has completely degraded. This was a single-arm, prospective, open-label study that enrolled 30 patients from four international centers: Auckland, Rotterdam, Krakow, and Skejby. Patients were eligible if they were above 18 years of age and had a diagnosis of stable, unstable, or silent ischemia. They were required to have a de novo lesion that was between 8 and 14mm in length with a reference vessel diameter of 3.
Exclusion criteria included acute myocardial infarction, poor ffating function, restenotic lesions, left main coronary artery disease, bifurcation lesions, or visible thrombus in the target vessel. The composite end-point of the study was cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization. Angiographic end-points, intravascular ultrasound, and derived morphology parameters were assessed at six months and were planned for two years following the initial procedure. Procedural success was achieved in all patients.
Stents fdating Biodegradable
After one-year of follow-up there was one non-Q-wave fcating and no stent thrombosis. There steents no target lesion revascularization at 12 months. Quantitative coronary angiography Bioddegradable an in-segment late loss of 0. Stenfs ultrasound analysis showed a significant reduction in stent area as a result of neointimal hyperplasia and possibly due to acute stent recoil or loss of radial Biodegdadable Biodegradable stents fdating to partial stent fdaying. A subset of patients also underwent optical coherence tomography OCT at six months to establish the degradation patterns of the stent, as well as to evaluate strut apposition.
The issues of reduced stent area and strut malapposition are concerning and represent challenges with a polymeric stent that may lack sufficient radial Biodegradaboe initially, and that further decreases with bioabsorption, resulting in recoil of the stent and malapposition at follow-up. Results showed that at two years there was one ischemia-driven MACE, no cardiac deaths, no stent thrombosis, and no ischemia-driven TLR. Follow-up IVUS was also performed in 28 of the 30 patients with measurements of the vessel, lumen, plaque, and minimal lumen area. Comparisons were made between results immediately following PCI and at six months and two years. Six months after PCI, there was some loss of lumen area and increase in plaque area felt to be secondary to neointimal hyperplasia.
At two years, minimal lumen area had increased and plaque area had decreased to levels similar to post-PCI. In addition, CT evaluation of the remaining stent struts revealed that more than one-third of strut sites had no remaining discernible features. Magnesium is a good choice for a bioabsorbable stents because of its biocompatibility and biocorrosion properties. Initial work using magnesium for the construction of coronary stents was carried out by Heublein. In vitro and in vivo studies of the magnesium alloy stent demonstrated that the overall integrity of the stent was preserved at 28 days, but high rates of degradation were evident from 60 to 90 days.
Further animal work in porcine coronary arteries demonstrated complete absorption of the stent in 56 days with no evidence of thromboembolic events. Twenty patients with severe infrapopliteal stenosis underwent angioplasty and implantation with an absorbable magnesium stent on a compassionate basis.
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